Overview
Durvalumab Long-Term Safety and Efficacy Study
Status:
Recruiting
Recruiting
Trial end date:
2022-10-31
2022-10-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AstraZenecaCollaborators:
CISCRP
Iqvia Pty Ltd
Medidata Solutions
ParexelTreatments:
Antibodies, Monoclonal
Durvalumab
Criteria
Inclusion Criteria:1. Patient must be 18 years or older, at the time of signing the ICF. For subjects aged <
20 years and enrolled in Japan, a written ICF should be obtained from the subject and
his or her legally acceptable representative.
2. Patient received durvalumab monotherapy and/or durvalumab containing combination in an
AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment
into this study.
3. Patients who received durvalumab in combination with any other approved or
investigational anticancer agents in the parent clinical study must have completed or
discontinued all other anticancer therapy (beyond durvalumab regimen).
4. Patient must be willing and able to provide written informed consent and to comply
with scheduled visits and other study procedures.
Exclusion Criteria:
The following exclusion criteria apply only to patients receiving treatment or retreatment:
1. Currently receiving treatment in another interventional study other than the parent
clinical study or, for retreatment patients, received treatment during the follow up
period with an agent other than durvalumab
2. Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment
3. Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent
discontinuation of durvalumab in parent clinical study
4. Diagnosis of a new primary malignancy since enrollment into the parent clinical study